Anchoring system for a medical article

ABSTRACT

An anchoring system for securing a catheter to a patient includes an anchor pad and a retainer. The retainer is supported by the anchor pad and includes a base and a cover. A groove upon the base is arranged to receive a branching site of a catheter where the lumens merge distal to the insertion site. One or more posts also protrude from the base to the cover at a position which will be disposed between the two distal branches of the catheter. The cover closes over the base, securing the branching site between the groove and the posts. The contact between the retainer and catheter thereby inhibits inadvertent motion of the catheter upon the patient. A latch mechanism is disposed upon the retainer to maintain the cover in a closed position over the branching site of the catheter on the base.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is the National Stage of International Application No.PCT/US2008/068854, filed Jun. 30, 2008, entitled ANCHORING SYSTEM FOR AMEDICAL ARTICLE, designating the U.S. and published in English on 7 Jan.2010 as International Publication No. WO 2010/002393, which is herebyincorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an anchoring system for securing amedical article to a patient to inhibit movement or migration of themedical article relative to the patient.

2. Description of the Related Art

Hospitalized patients often have limited mobility due either to theircondition or to doctor's orders. Such patients must lie in bed and notmove about their hospital room, even to urinate. As such, a Foleycatheter is often used with the bed-confined patient to drain urine fromthe patient's bladder. Use of a Foley catheter thus eliminates toilettrips as well as reduces bedpan use.

A Foley catheter may include three coaxial lumens: a drainage lumen, aninflation lumen, and an auxiliary lumen. The inflation lumencommunicates with an inflation balloon located at the tip of thecatheter (i.e., the catheter proximal end). The proximal end of thedrainage lumen includes one or more influent openings to receive urinefrom the bladder. The lumens usually diverge in a trident pattern at thedistal end of the catheter to form an effluent port, an auxiliary port,and an inflation port.

In use, a healthcare provider inserts the Foley catheter through theurinary tract of the patient to locate the tip of the catheter withinthe patient's bladder. The healthcare provider often applies lubricantto the outer surface of the catheter. The provider then inflates theballoon by attaching the inflation port to a source of pressurizedworking fluid (e.g., saline solution). Once inflated, a valve, which islocated at the inflation port, inhibits the flow of fluid from theinflation lumen and the balloon to keep the balloon inflated. Theinflated balloon prevents the catheter from unintentionally dislodgingfrom the bladder. The healthcare provider then connects the distal endof the drainage lumen (i.e., its effluent port) to a drainage tubeleading to a collection container. The third lumen may be intermittentlyconnected to a source of liquids to irrigate the bladder.

The healthcare provider usually secures the distal end of the Foleycatheter to the patient using tape. The healthcare provider commonlyplaces long pieces of tape across the distal end of the catheter in acrisscross pattern to secure the catheter distal end to the inner thighof the patient. This securement inhibits disconnection between thecatheter and the drainage tube, as well as prevents the catheter ordrainage tube from snagging on the bed rail or other objects.

Taped connections, however, often collect contaminants and dirt. Normalprotocol therefore requires periodic tape changes in order to inhibitbacteria and germ growth at the securement site. Frequent tape changesthough lead to another problem: excoriation of the patient's skin. Inaddition, valuable time is spent applying and reapplying the tape tosecure the catheter. And healthcare providers often remove their gloveswhen taping because most find the taping procedure difficult andcumbersome when wearing gloves. Not only does this further lengthen theprocedure, but it also subjects the healthcare provider to possibleinfection.

SUMMARY OF THE INVENTION

Embodiments of the present invention involve several features for ananchoring system useful for the securement of a medical article to apatient's body. Without limiting the scope of this invention, its moreprominent features will be discussed briefly. After considering thisdiscussion, and particularly after reading the Detailed Description ofthe Preferred Embodiments section below in combination with thissection, one will understand how the features and aspects of theseembodiments provide several advantages over prior securement devices.

One aspect of the present invention is a catheterization system thatsecures at least a portion of a catheter. The system can include acatheter, retainer, latching mechanism, and an anchor pad. The cathetercan have an elongated body and a branching site with at least threeelongated sections extending from the branching site. The retainer caninclude a base, a cover and at least two posts. The cover can bemoveable with respect to the base between an open position and a closedposition. The base and the cover further can have generally curvilineargrooves that together form a channel when the cover is in the closedposition. The posts on the retainer can be disposed in the channel sothat the channel and the posts define a shape that generally matches theshape of the branching site and the elongated sections of the catheter.Further, each post can have a contact surface configured to abut againstthe catheter at the branching site, inhibiting movement of the securedportion of the catheter in at least one direction. The channel and theat least two posts can also support the secured portion of the catheterat least when the cover is in the closed position. The latchingmechanism can be operable between the base and the cover to releasablysecure the cover to the base. The anchor pad can support the retainer.The anchor pad can also have an upper surface and a lower surface, atleast a portion of the lower surface being formed with an adhesive layerfor contacting a patient's skin.

Another aspect of the invention is a catheterization system that securesa silicone catheter. The system can include a catheter, an anchor pad, aretainer, at least one protrusion, and a latching mechanism. Thecatheter can have an elongated body and a branching site, at least threeelongated sections extending from the branching site. The anchor pad canhave an upper surface and a lower surface, at least a portion of thelower surface being formed with an adhesive layer to which the retainercan attach. The retainer can also include a base and a cover. The basecan comprise a first generally curvilinear groove and the cover can bemovable with respect to the base between an open position in which thefirst groove is exposed and a closed position in which at least aportion of the first groove is covered. The cover can include a secondgenerally curvilinear groove that cooperates with the first groove whenthe cover is in the closed position to define a channel having a shapethat substantially matches a shape of the catheter. The channel canfurther be configured to support the secured portion of the siliconecatheter. The at least one protrusion can be disposed in the channel andhave a rounded distal end, with at least the distal end interacting withthe catheter when the cover is in the closed position. The latchingmechanism can operate between the base and the cover to releasablysecure the cover to the base.

Another aspect of the invention is a securement device for securing anelongated medical article. The device includes an anchor that has anupper surface and a lower surface. At least a portion of the lowersurface is formed with an adhesive layer. The device further includes aretainer that has a base and a cover. The cover is moveable with respectto the base between an open position and a closed position. Each of thebase and the cover has a generally curvilinear groove. The groovestogether form a channel when the cover is in the closed position. Thechannel supports the secured portion of the catheter at least when thecover is in the closed position. The device further includes a latchingmechanism operable between the base and the cover to releasably securethe cover to the base when the cover is in the closed position. Thelatching mechanism includes a keeper, a latch, a latch post, and a latchpost receiving portion. The keeper has at least one member capable ofinterengaging with at least a portion of the base, and the latch has arecess for accepting at least a portion of the member when the cover isin the closed position. The latch post interengages with the latch postreceiving portion so as to structurally support the latching mechanismwhen the cover is in the closed position.

Another aspect of the invention is a retainer for securing a catheterhaving an elongated body, a branching site, and at least three elongatedsections extending from the branching site. The retainer can comprise abase and a cover, the cover being moveable with respect to the basebetween an open position and a closed position. Each of the base and thecover can have a generally curvilinear groove, with each grooveextending between longitudinal ends of the retainer and forming achannel when the cover is in the closed position. The channel formed bythe grooves can have one or more recesses, formed in the base and in thecover, configured to receive a portion of the catheter. Each recess canhave a longitudinal length less than a longitudinal length of theretainer so as to form a ridge at each end of the channel. Each ridge inthe cover can then cooperate with the corresponding ridge in the basewhen the cover is in the closed position to define a portion of thechannel. The retainer can further comprise a latching mechanism operablebetween the base and the cover to releasably secure the second side ofthe cover to the second side of the base.

Another aspect of the invention is a method of releasably anchoring asilicone catheter including a branching site onto a patient. Ananchoring device having an adhesive lower surface and a retainersupported by the anchoring device can be provided. The retainer can havea base, a cover, and at least two retaining members. The base can havegenerally curvilinear proximal and distal rims, at least one protrusion,and a recessed portion disposed between said rims. Further, the base andthe cover can together form a channel when the cover is secured in aposition over at least a portion of the base. At least a branching siteof the silicone catheter can be inserted into the recessed portion ofthe base such that at least one branch of the silicone catheter lies toeach side of each of the at least two retaining members of the base. Thecover can be positioned over at least a portion of the base. The covercan be secured in a position overlying the covered portion of the base,the secured cover pressing at least a portion of the silicone catheteragainst the at least one protrusion to inhibit movement of the securedportion of the catheter relative to the retainer. Further, the anchoringdevice can be secured to the skin of the patient via the adhesive lowersurface of the anchoring device.

Another aspect of the invention is a catheterization system for securingat least a portion of a catheter. The system can comprise a catheter, aretainer, a latching mechanism, and an anchor pad. The catheter can havean elongated body, a branching site, at least two elongated sectionsextending from the branching site, and a webbing between the elongatedsections comprising at least one hole. The retainer can include a base,a cover, and at least one post. The cover can be moveable with respectto the base between an open position and a closed position. Each of thebase and the cover can have a generally curvilinear groove, the groovestogether forming a channel when the cover is in the closed position. Theat least one post can be disposed in the channel so that the channel andthe at least one post define a shape that generally matches a shape ofthe branching site and the at least two elongated sections of thecatheter. At least when the cover is in the closed position the at leastone post is configured to pass through the at least one hole in thewebbing of the catheter. The channel and the at least one post supportthe secured portion of the catheter. The latching mechanism can operatebetween the base and the cover to releasably secure the cover to thebase. The anchor pad can support the retainer, with an upper surface anda lower surface. At least a portion of the lower surface can be formedwith an adhesive layer for contacting a patient's skin.

These and other aspects of the present invention will become readilyapparent to those skilled in the art from the following detaileddescription of the preferred embodiments, which refers to the attachedfigures. The invention is not limited, however, to the particularembodiments that are disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the anchoringsystem disclosed herein are described below with reference to thedrawings of preferred embodiments, which are intended to illustrate andnot to limit the invention. Additionally, from figure to figure, thesame reference numerals have been used to designate the same componentsof an illustrated embodiment. Like components between the illustratedembodiments are similarly noted as the same reference numbers with aletter suffix to indicate another embodiment. The following is a briefdescription of each of the drawings.

FIG. 1 is an exploded, perspective view of a preferred embodiment of ananchoring system configured in accordance with the present invention andshows a cover of a retainer in an open position;

FIG. 2 illustrates a perspective view of the anchoring system of FIG. 1with the retainer assembled to an anchor pad;

FIG. 3 illustrates a perspective view of the anchoring system of FIG. 1with the cover in a closed position;

FIG. 4 illustrates a perspective view of the retainer from the anchoringsystem of FIG. 1 with the cover in an open position;

FIG. 5 illustrates a plan view of the retainer from the anchoring systemof FIG. 1 showing the exterior surfaces of the retainer with the coverin the open position;

FIG. 6 illustrates a plan view of the retainer from the anchoring systemof FIG. 1 showing the interior surfaces of the retainer with the coverin the open position;

FIG. 7 illustrates a side view of the retainer taken along lines 7-7 inFIG. 6;

FIG. 8 illustrates a side view of the retainer taken along lines 8-8 inFIG. 6;

FIG. 9 illustrates a cross-sectional view of the cover of the retainerfrom FIG. 6 along the lines 9-9;

FIG. 10 illustrates a cross-sectional view of the base of the retainerfrom FIG. 6 along the lines 10-10;

FIG. 10A illustrates a cross-sectional side view of the base from FIG.10 assembled to a mounting base for rotation;

FIG. 10B illustrates an enlarged cross-sectional view from FIG. 10Ashowing a post of the mounting base engaged with a hole in the base ofthe retainer;

FIG. 11 illustrates a cross-sectional view of the retainer from FIG. 6along the lines 11-11;

FIG. 12 illustrates a cross-sectional view of the retainer from FIG. 6along the lines 12-12;

FIG. 13 illustrates a perspective view of a catheter to be retained bythe anchoring system illustrated in FIG. 1;

FIG. 14 illustrates the catheter from FIG. 13 aligned with the anchoringsystem of FIG. 1;

FIG. 15 illustrates the catheter of FIG. 13 inserted in the retainer ofFIG. 4;

FIG. 15A illustrates an enlarged perspective view of the retainer ofFIG. 4 in an open position;

FIG. 16 illustrates the retainer of FIG. 15 in a closed position;

FIGS. 17A-C illustrate cross-sectional views of the catheter andretainer of FIG. 16 along the lines 17A-17A, 17B-17B, and 17C-17C,respectively;

FIG. 18 illustrates the retainer of FIG. 4 in an intermediate position;

FIG. 19 illustrates the retainer of FIG. 4 near a closed position;

FIG. 20 illustrates the retainer of FIG. 4 in a closed position;

FIG. 21 illustrates a perspective view of another embodiment of theretainer with the cover in an open position;

FIG. 22 illustrates a plan view of the retainer from FIG. 21 showing theinterior surfaces of the retainer with the cover in the open position;

FIG. 23 illustrates a cross-sectional view of the retainer from FIG. 22along the lines 23-23;

FIG. 24 illustrates a cross-sectional view of the retainer from FIG. 22along the lines 24-24;

FIG. 25 illustrates a perspective view of a catheter to be retained bythe retainer from FIG. 21;

FIG. 26 illustrates the catheter from FIG. 25 aligned with the retainerof FIG. 21;

FIG. 27 illustrates the catheter of FIG. 25 inserted in the retainer ofFIG. 21;

FIG. 28 illustrates the retainer of FIG. 26 in a closed position; and

FIGS. 29A-C illustrate cross-sectional views of the catheter andretainer of FIG. 28 along the lines 29A-29A, 29B-29B, and 29C-29C,respectively.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present embodiment of the medical article anchoring system isdisclosed in the context of an exemplary 3-way Foley type catheter. Theprinciples of the present invention, however, are not limited to 3-wayFoley catheters. Instead, it will be understood by one of skill in thisart, in light of the present disclosure, that the anchoring system andretainer disclosed herein also can be successfully utilized inconnection with other types of medical articles, including other typesof catheters, fluid drainage and delivery tubes and electrical wires.For example, but without limitation, the retainer disclosed herein canalso be configured to receive and secure central venous catheters,peripherally inserted central catheters, hemodialysis catheters,surgical drainage tubes, feeding tubes, chest tubes, nasogastric tubes,scopes, as well as electrical wires or cables connected to external orimplanted electronic devices or sensors. One skilled in the art can alsofind additional applications for the devices and systems disclosedherein. Thus, the illustration and description of the anchoring systemin connection with a Foley catheter is merely exemplary of one possibleapplication of the anchoring system.

The anchoring system described herein is especially adapted to arrestaxial movement of a catheter with a slippery coating, as well as hold acatheter against the patient. For this purpose, the anchoring system 10utilizes one or more retention elements. The anchoring systemaccomplishes this though without meaningfully impairing (i.e.,substantially occluding) the fluid flow through the catheter to a degreethat would create complications. As described below, such retentionelements involve, among others, the shape of the channel that retains asection of the catheter, a retaining member either aligned with orpositioned within the channel, a securement protrusion(s) and/orfriction ridge(s) that bites into the catheter body withoutsubstantially occluding the catheter drainage lumen, and/or cooperatingmembers that come together to clamp onto or pin a portion of thecatheter (e.g., a webbing formed between the branches at the Foleycatheter branching-site).

The anchoring system also desirably releasably engages the catheter.This allows the catheter to be disconnected from the anchoring system,and from the patient, for any of a variety of known purposes. Forinstance, the healthcare provider can want to remove the catheter fromthe anchoring system to ease disconnection of the catheter from thedrainage tube or to clean the patient. The disengagement of the catheterfrom the anchoring system, however, can be accomplished without removingthe anchoring system from the patient.

Before describing the present anchoring system in detail, a briefdescription of a Foley catheter is provided to assist the reader'sunderstanding of the exemplary embodiment that follows. As bestunderstood from FIG. 13, the catheter 8 includes a proximal tip with aninflatable balloon (not shown) and a distal end 110. The distal end 110includes a branching site 112 formed by an inflation branch 114,auxiliary branch 117, and a drainage branch 116. The branches 114, 116,117 merge together at the branching site 112. The lumens of thesebranches assume either a coaxial or side-by-side arrangement on theproximal side of the branching site 112 to form a main catheter body118. On the distal side of the branching site 112, a webbing 120 canextend between the branches 114, 116, 117 next to the branching site112. As shown in the illustrated embodiment, the drainage branch 116 canbe positioned in between the auxiliary branch 117 and the inflationbranch 114. As further depicted, the drainage branch 116 can comprise agenerally circular shape with a diameter greater than the other branches114, 117. It will be clear from the disclosure herein that the branchescan be configured in other orders and comprise other shapes (e.g.generally elliptical, square, triangular, etc.) and sizes. Asillustrated in FIGS. 17A-C and 29A-C, these branches can be retained bya cover 24 and base 22 of the retainer 20.

In various embodiments, the auxiliary branch 117 can be configured toperform one or more different functions. In some embodiments theauxiliary branch 117 comprises an irrigation branch (as shown). Theirrigation branch can allow fluid to be passed from a distal portion toa proximal portion. This fluid can then wash an internal cavity of apatient and flow back out through the drainage branch 116. As anotherexample, in some embodiments the auxiliary branch 117 is configured as athermocouple branch. The thermocouple branch can include a thermocouple.The thermocouple can extend through the main catheter body 118 andmeasure the temperature at a proximal end of the catheter 8. At thedistal end of the thermocouple branch an electronic connection can beprovided to allow a user to connect the thermocouple to an electronicdevice. The electronic device can translate an input voltage, current,or other electrical property sensed by the thermocouple into ahuman-perceivable temperature measurement or indication. Measurements ofother characteristics of the patient, catheter, and/or fluids passingwithin the auxiliary branch 117 are also within the scope of theinvention as would be understood by those skilled in the art.

With reference now to FIGS. 1-3, the anchoring system 10 includes ananchor pad 12 and a retainer 20. The anchor pad 12 secures the retainer20 to a patient's skin. The anchor pad 12 has a lower adhesive surface16 which adheres to the skin of a patient and a roughened upper surface14 which supports a retainer 20.

The anchoring system 10 may further include a mounting base 242. Themounting base 242 connects the retainer 20 to the anchor pad 12 andallows the retainer 20 to rotate relative to the anchor pad 12. Theretainer 20 preferably rotates by at least some degree, and morepreferably by 360 degrees, relative to the anchor pad 12. For thispurpose, in the illustrated embodiment, a mounting post 226 is attachedto the anchor pad 12 and a hole 232 is formed in the base 22 of theretainer 20. However, the anchoring system 10 need not include themounting base 242. In other embodiments, the retainer 20 directlyconnects to the anchor pad 12 and does not rotate relative to the anchorpad 12.

The retainer 20 is configured to accept and retain a section of a Foleycatheter 8 within the anchoring system 10. In the illustratedembodiment, the retainer 20 comprises a base 22 and a cover 24. Thecover 24 is detachably secured to the base 22 and moveable between openand closed positions.

To assist in the description of these components of the anchoring system10, the following coordinate terms are used. A “longitudinal axis” isgenerally parallel to the section of the catheter 8 retained by theanchoring system 10. A “lateral axis” is normal to the longitudinal axisand is generally parallel to the plane of the anchor pad 12. A“transverse axis” extends normal to both the longitudinal and lateralaxes. In addition, as used herein, “the longitudinal direction” refersto a direction substantially parallel to the longitudinal axis; “thelateral direction” refers to a direction substantially parallel to thelateral axis; and “the transverse direction” refers to a directionsubstantially parallel to the transverse axis. Also, the terms“proximal” and “distal”, which are used to describe the presentanchoring system 10, are used consistently with the description of theexemplary application. Thus, proximal and distal are used in referenceto the center of the patient's body. A detailed description of theanchoring system 10, and its associated method of use, now follows.

FIGS. 1-3 illustrate an anchor pad 12 which desirably comprises alaminate structure with an upper foam layer (e.g., closed-cellpolyethylene foam), and a lower adhesive layer. The lower adhesive layerconstitutes the lower surface 16 of the anchor pad 12. The lower surface16 desirably is a medical-grade adhesive and can be either diaphoreticor nondiaphoretic, depending upon the particular application. Such foamwith an adhesive layer is available commercially from Avery Dennison ofPainsville, Ohio. Further, the anchor pad 12 can include suture holes201 in addition to the adhesive layer 16 to further secure the anchorpad 12 to the patient's skin.

A surface of the upper foam layer constitutes an upper surface 14 of theanchor pad 12. The upper surface 14 can be roughened by corona-treatingthe foam with a low electric charge. The roughened or porous uppersurface 14 can improve the quality of the adhesive joint (which isdescribed below) between the retainer 20 and the anchor pad 12. In thealternative, the flexible anchor pad 12 can comprise a medical-gradeadhesive lower layer, an inner foam layer and an upper paper or otherwoven or nonwoven cloth layer.

A removable paper or plastic release liner 18 desirably covers theadhesive lower surface 16 before use. The liner 18 preferably resiststearing and desirably is divided into a plurality of pieces to easeattachment of the pad to a patient's skin. In the illustratedembodiment, the liner 18 is split along a center line 19 of the flexibleanchor pad 12 in order to expose only half of the adhesive lower surface16 at one time.

The liner 18 length, as measured in the lateral direction, extendsbeyond the center line 19 of the anchor pad 12 and is folded over, orback onto the liner 18. This folded over portion defines a pull tab 17to facilitate removal of the liner 18 from the adhesive lower surface16. A healthcare provider uses the pull tab 17 by grasping and pullingon it so that the liner 18 is separated from the lower surface 16. Thepull tab 17 overcomes any requirement that the healthcare provider pickat a corner edge or other segment of the liner 18 in order to separatethe liner 18 from the adhesive layer. The pull tab 17 of course can bedesigned in a variety of configurations. For example, the pull tab 17need not be located along a center line 19 of the anchor pad 12; rather,the pull tab 17 can be located along any line of the anchor pad 12 inorder to ease the application of the anchor pad 12 onto the patient'sskin at a specific site. For example, an area of a patient's skin withan abrupt bend, such as at a joint, can require that the pull tab 17 bealigned toward one of the lateral ends of the anchor pad 12 rather thanalong the center line 19.

In the illustrated embodiment, the anchor pad 12 also desirably includesa pair of opposing concave sections 13, 15 that narrows the center ofthe anchor pad 12 proximate to the base 22. As a result, the lateralsides of the anchor pad 12 have more contact area which provides greaterstability and adhesion to a patient's skin.

With reference now to FIGS. 4-10, the retainer 20 includes a rigidstructure principally formed by the base 22 and the cover 24. In theillustrated embodiment, the base 22 and cover 24 are integrally formedto comprise a unitary retainer 20. This can be accomplished in any of avariety of ways well known to those skilled in the art. For instance,the entire retainer 20 can be injection molded to reduce fabricationcosts.

Additionally, as will be apparent from the below description, severalfeatures of the retainer 20 (e.g., a latch keeper and a hinge) desirablyare flexible. In some embodiments, it will be desirable to use materialsthat are capable of producing shapes that are flexible in defined areasbut rigid in other areas. Suitable ridged but flexible materialsinclude, for example, but without limitation, plastics, polymers orcomposites such as polypropylene, polyethylene, polycarbonate,polyvinylchloride, acrylonitrile butadiene styrene, nylon, olefin,acrylic, polyester, as well as moldable silicon, thermoplastic urethane,thermoplastic elastomers, thermoset plastics and the like. Theillustrated retainer 20 preferably is formed by injection molds usingpolyethylene or polypropylene material. However, other materials can beutilized, and the retainer 20 can comprise a non-unitary base 22 andcover 24.

With reference to FIG. 4, a base 22 in the illustrated embodimentcomprises an elongated body of a generally parallelepiped shape. Thebase 22, however, can be configured in a wide variety of shapes as well,such as circular, square, triangular or the like in order to suit aparticular application. The longitudinal dimension of the base 22desirably is sufficiently long to provide stability to the catheter 8along its length. That is, the longitudinal length of the retainedcatheter portion is sufficient to inhibit rocking of the catheter 8relative to the retainer 20 (i.e., to prevent the retainer 20 fromacting as a fulcrum for the catheter). Also, the lateral dimension ofthe base 22 desirably allows the healthcare provider to easily andnaturally grip the base 22, as well as provides space on which to locatea hinge 40 and a portion of the latch mechanism 80. As will be clearfrom the description herein, other embodiments of the retainer 20 may bedesirably short, so as to allow the retainer 20 to act as a fulcrum inany one or more dimensions. For example, in some embodiments it may bedesirable to allow more play in the angle of the catheter 8 near theretainer 20 (e.g. if the retainer 20 is generally close to thepatient-insertion point, but not angularly aligned therewith).

As best depicted in FIGS. 5 and 6, the base 22 includes first and secondsides 26, 28. The first side 26 lies generally at one lateral end of thebase 22, and the second side 28 lies at an opposite lateral end of thebase 22.

A groove 30 is formed on the base 22 between the first side 26 and thesecond side 28. In the illustrated embodiment, the groove 30 has agenerally curvilinear cross-sectional shape. As best seen in FIGS. 6,10, the lower groove 30 is also varied in width (i.e., in the lateraldirection) along its longitudinal length. That is, in the illustratedembodiment, the side walls of the lower groove 30 diverge from eachother in a generally linear manner from one longitudinal side of theretainer 20 to the other longitudinal side of the retainer.

The base 22 of the retainer 20 is supported by the upper surface 14 ofthe anchor pad 12. In the illustrated embodiment, the mounting base 242desirably is secured to the upper surface 14 by a solvent bond adhesive,such as cyanoacrylate or other bonding material. One such adhesive isavailable commercially as Part No. 4693 from the Minnesota Mining andManufacturing Company (3M).

As also seen in FIGS. 5, 6, the cover 24 can have an elongate shapewhich desirably is coextensive with the planar size and shape of thebase 22 (i.e., desirably has the same general geometric shape and sizeas the base 22); however, the cover 24 need not be the same size orshape as the base 22. For instance, the cover 24 can be sized to extendbeyond any of the lateral, traverse, or longitudinal edge of the base 22or, alternatively, can be sized so as to not extend to the lateral,traverse, or longitudinal edge of the base 22. The cover can alsoinclude a skirt or flange that extends over and/or about the base 22 orany portion thereof.

The cover 24 though desirably has a sufficient size to cover the lowergroove 30 in the base and to accommodate a portion of the latchmechanism 80 and the hinge 40 which operate between the base 22 and thecover 24, as described below. The cover 24 also desirably is of adimension which provides for easy manipulation. For example, the cover'ssize easily accommodates the grasp of a healthcare provider.

The cover 24 includes a first side 32 which lies generally at onelateral end of the cover. The first side 32 of the cover 24 thereforegenerally corresponds to the first side 26 of the base 22. The cover 24also comprises a second side 34. The second side 34 lies generallytoward a lateral end of the cover 24, opposite of the first end, andcorresponds generally to the second side 28 of the base 22.

An upper groove 36 is formed on an inner side of the cover 24 betweenthe first and second sides 32, 34 of the cover 24 and correspondsgenerally to the lower groove 30 formed in the base 22. The width of theupper groove 36 is also varied in the lateral direction along itslongitudinal length. That is, in the illustrated embodiment, the sidewalls of the upper groove 36 diverge from each other in a generallylinear manner from one longitudinal end of the cover 24 to the otherlongitudinal end.

The cover 24 is flexibly coupled to the base 22 by way of a flexiblecoupling or hinge 40. The coupling 40 desirably comprises a flexibleband 42 that can take any number of forms to mechanically connect thecover 24 to the base 22 while permitting pivotal movement of the cover24 relative to the base 22 so as to enable engagement or disengagementof these parts, as described below. In the illustrated embodiment, theband 42 is formed of flexible material, desirably of the same materialfrom which the base 22 and cover 24 are comprised. Advantageously, thehinge 40 is integrally molded with the base 22 and the cover 24 to forma unitary member, as noted above. The hinge 40 is located at an outeredge of the base 22 and the cover 24; however, the hinge 40 need not belaterally located at an extreme end of the base 22 or cover 24.

As best understood from FIG. 5, the width of the hinge 40, as measuredin the longitudinal direction, is desirably less than that of either thebase 22 or the cover 24 to allow some leeway or play when engaging ordisengaging the cover 24 to the base 22. That is, this shape allows thehinge 40 to twist to some degree to compensate for some manufacturingtolerances; however, the hinge 40 can have at least as large of alongitudinal dimension as the base 22 and the cover 24.

The hinge 40 is desirably integrally formed along a common correspondingexterior surface of the cover 24 and base 22. In the illustratedembodiment, as best understood from FIGS. 7, 8, the hinge 40 hasgenerally a U-shape, and extends from both the base 22 and the cover 24in the lateral direction to the side of the retainer 20. A gap (notshown), corresponding to a transverse height of the hinge 40, existsbetween the base 22 and cover 24, near the hinge when in the closedposition. This gap, however, can be reduced or eliminated from theretainer 20 for some applications by using a different hinge design.

The hinge 40 enables the cover 24 to move between the open position andthe closed positions. The open position, as illustrated in FIG. 4, ischaracterized by exposing at least a portion of the grooves 30, 36 inthe base 22 and the cover 24 in the transverse direction and therebyspacing apart the base 22 and the cover 24. When in the open position,the retainer 20 is capable of receiving a portion of a Foley catheter 8(e.g., the branching site 112). The closed position, as illustrated inFIG. 3, is characterized by the cover 24 lying in contact or nearcontact with the base 22 so as to position the upper groove 36 above thelower groove 30. When in the closed position, the retainer 20substantially surrounds the received portion of the catheter.

The hinge 40 need not provide 180 degrees of movement of the cover 24relative to the base 22 to establish the closed position and a fullyopen position, as illustrated by FIGS. 3, 4. For instance, the hinge 40can permit a smaller degree of movement (e.g., 90 degrees) between thebase 22 and the cover 24 while still providing enough space totransversely insert the catheter into the retainer 20.

As best illustrated in FIGS. 18-20, the grooves 30, 36 formed in thebase 22 and the cover 24 define a channel 60 when the retainer 20 isclosed. The channel 60 is capable of receiving a portion or length ofthe catheter 8 and is generally configured to house, grip and secure theaffected catheter portion. The channel 60 can have a variety ofconfigurations, as discussed above in connection with the grooves 30,36, in order to accommodate a particular medical article. In theillustrated embodiment, the channel 60 generally has roundedcross-sectional shapes at its proximal end and a generally oblongcross-sectional shape at its distal end (although, in the illustratedembodiment, the distal end is divided by pairs of cooperating posts,which will be described below). The channel 60 smoothly tapers incross-sectional size from its smaller proximal end to its larger distalend. The channel 60 consequently generally has a truncated V-shape, asbest understood by inspecting the shapes of the grooves 30, 36 in FIG.6. In a preferred embodiment, the channel 60 can be shaped and sized tosubstantially match the catheter 8.

In the embodiment illustrated in FIGS. 1-10, the lateral sides of thechannel 60 are generally straight and diverge from each other. The wallsof the channel 60 (and, thus, the grooves of the cover and base),however, need not be straight. For example, the wall of the base groove30 can have a convex bulge (not shown) that narrows the portion of thechannel that receives the inflation branch 114 of the catheter. Thischannel shape furthers retention of the catheter within the channel 60to inhibit catheter movement through the channel, as discussed below.

Although the channel 60 can take the form of various shapes dependingupon its application (i.e., depending upon a shape of the retainedportion of the medical article 8 for which the retainer is designed tobe used), the channel 60 preferably has a sufficient length in thelongitudinal direction to stabilize the catheter, rather than act as afulcrum for the catheter, as mentioned above. That is, the retainerpreferably receives a sufficient length of the catheter 8 to inhibitmovement of the catheter in the lateral, longitudinal and transversedirection (i.e., to inhibit yaw, pitch and axial movement of thecatheter), without kinking the catheter. Also, the wide-mouth shape(i.e., the large oval-shape) of the channel proximal opening eliminatesan edge or surface over which the catheter could kink. It will be clearfrom the disclosure herein, that a shorter retainer 20 may be used ifother movement inhibiting elements are included, or if certain movementsof the medical article 8 are tolerable.

When the cover 24 is closed, a section of the catheter 8 is capturedwithin the retainer 20. Thus, the retainer 20 at least restricts, if notprevents, lateral and transverse movement of the retained section of thecatheter 8.

Inhibiting movement of the catheter 8 in the longitudinal direction whenthe catheter 8 is secured within the channel 60 is desirablyaccomplished by one or more retention elements that associate with thechannel 60. With reference to FIG. 6, one such retention elementinvolves the shape of the channel 60 itself. The interaction between thetruncated V-shape of the channel 60 and a corresponding shape of thecatheter branching site 112 inhibits proximal longitudinal movement.

As best understood from FIGS. 14, 15 the proximal end of the channel 60is sized to receive only the main body 118 of the catheter 8. The distalend of the channel 60 is sized to receive the branches 114, 116, 117(i.e., the inflation lumen section, the auxiliary lumen section, and thedrainage lumen section) at the distal side of the branching site 112.And between its distal and proximal ends, the channel 60 is configuredto receive the catheter branching site 112.

Because the catheter branching site 112 is larger in cross-section thanits main body 118 and because of the presence of a large valve which isattached to the catheter inflation branch (see FIG. 12), the branchingsite 112 usually cannot be pulled proximally through the smallerproximal end of the retainer channel 60. The shape of the channel 60thus inhibits longitudinal movement of the catheter in the proximaldirection.

As best shown in FIGS. 9, 10, the channel 60 can further compriserecessed portions 280 on both the cover 24 and base 22. The recessedportions 280 illustrated are substantially flat with curved edges 281along their lateral sides. On both longitudinal sides of the recessedportions 280, the retainer 20 can comprise rims 282 (best illustrated inFIGS. 11, 12, and 15A) that are substantially curved and generally matchthe corresponding portions of the catheter 8. The rims 282 can beoriented generally in the transverse-lateral plane, generallyperpendicular to the channel 60. Further, the rims 282 can generallyslope to match the channel 60 in the center of the channel 60 and/ornear the curved edges 281. As will be described below, the recessedportions 280 can allow space for a catheter 8 to bulge, facilitating itssecurement in the retainer 20.

Variations on the channel's shape are also possible. For instance,opposing lateral sides of the channel 60 can vary from each other in acurvilinear manner and/or can include a gouge, bulge, or similargeometric abnormality so as to cooperate with or impinge upon acorresponding portion of the received catheter length. Also, there is norequirement that either or both lateral sides vary relative to an axisof the received catheter length. Either or both sides can vary indistance relative to a longitudinal axis of the received catheter lengthso as to inhibit longitudinal movement of the retained section of thecatheter 8. The channel, however, can have a straight or uniformcross-sectional shape where the retainer includes at least another modeof the retention elements described herein.

Interaction between the surface 69 of the retainer channel 60 and thecatheter branching site 112 can also create friction to inhibitlongitudinal movement through the channel 60. The degree of interferencebetween the catheter 8 and the retainer 20, however, is preferably notso great as to significantly occlude the catheter 8.

In alternative embodiments, the channel surface 69 may comprise varioussurface features to enhance retention of the catheter 8. For example,the channel surface 69 may comprise friction ridges (not shown). Suchridges and other surface features can be used together with or in thealternative to the other retention elements discussed herein. The ridgesare desirably of smooth solid construction; however, they can be ofrough and/or hollow construction. The ridges can have generallytriangular cross-sectional shapes and angle toward one end of thechannel 60 (e.g., the distal end), or the ridges can have othercross-sectional shapes which would interfere with axial movement of thecatheter 8 through the channel 60.

One or more retaining members, which protrude into the channel 60, canalso inhibit axial movement of the catheter 8. The retaining membersform an upstanding member transversely positioned relative to the anchorpad 12. The retaining members are arranged to lie between the branchesat the catheter branching site 112 retained by the retainer 20 so as toinhibit axial movement of the catheter 20 in the distal direction. Thus,in the illustrated embodiment, the combination of the tapering channelshape and the retaining members inhibits axial movement of the retainedsection of the catheter 8 in both the proximal and distal directions.

The retaining members desirably have a sufficient height to inhibitaxial movement of the catheter 8 in the distal direction. For thispurpose, the retaining member has a height, in the transverse direction,of at least about 25% of the height of the channel 60 at the location atwhich the structure is positioned. In the illustrated embodiment, theretaining member desirably extends across channel 60.

In the illustrated embodiment, each retaining member is formed by a basepost 74 and a cover post 78. The base post 74 desirably is integrallyformed with the base 22, and is located in the channel 60 toward thedistal end of the channel 60. The cover post 78 is integrally formedwith the cover 24 also at the distal end of the channel 60. Although inthe illustrated embodiment, the base post 74 and cover post 78 liewithin the channel 60, the posts 74, 78 can be located outside or insidethe distal end of the channel 60.

In one mode, a base post 74 is sized to extend to a position where itsupper end lies near or contacts the webbing 120 of the catheter 8 thatextends between the branching site branches 114, 116, 117. In theillustrated embodiment, the upper end of the post 74 lies generallyabove a plane defined by the upper surface of the base 20 when in anopen position, as best seen in FIGS. 7, 8. The cover post 78 similarlyextends to a point which is generally below a plane defined by the innersurfaces of the cover (that lie adjacent to the base 22 when in a closedposition), when in an open position as depicted in FIGS. 7, 8. In otherembodiments, it may be desirable to provide the posts 74, 78 flush witha plane defined by the respective surfaces of the cover or the base, orreversing their positions relative to the cover or the base. In someembodiments, the base post 74 should be sufficiently large to preventlongitudinal or lateral movement of the catheter 8 when the retainer 20is in an open position. The cover post 78 can then be sized such that,in cooperation with the base post 74, the posts form a retaining membersufficient to prevent longitudinal movement of the catheter 8 when theretainer is in a closed position.

As best seen in FIGS. 14, 15, the lateral position of the posts 74within the channel 60 can correspond with the merge points between thebranches 114, 116, 117 of the Foley catheter 8. The posts 74 divide thechannel 60 at the channel's distal end as shown. However, as discussed,the posts 74 may divide the channel 60 at other points, including deeperwithin the channel, outside the channel, or at the channel's proximalend. Further, when there are multiple posts 74, as in the illustratedexemplary embodiment, each post may be provided at an approximatelyequal longitudinal position, or an unequal longitudinal position. Forexample, in some embodiments the retainer 20 may be configured to fit acatheter 8 wherein there are two branching sites (longitudinally)instead of one. In this instance, it may be desirable to position theposts 74 at accordingly different longitudinal positions to better fitthe catheter 8.

The cover post 78 can be configured and arranged on the cover 24 in amanner similar to that described above in connection with the base post74 on the base 22. In the illustrated embodiment, the post 78 thusgenerally opposes the base post 74. By this particular design, asunderstood from FIG. 6, the combination of the posts 74, 78 and thechannel 60 define a generally fork-shaped recess between the channel'sproximal and distal ends.

In the illustrated embodiment, the transverse height of the cover post78 is less than that of the base post 74. The posts 74, 78, however, canhave equal heights or the cover post 78 can be longer than the base post74. Together though, the posts 74, 78 desirably span the channel 60 inthe transverse direction.

The posts 74, 78 thus extend between the branches 114, 116, 117 of thecatheter 8 when the catheter branching site 112 is positioned within thechannel 60. Together the posts 74, 78 can act as a stop againstlongitudinal movement of the catheter 8 in the distal direction. Thatis, longitudinal movement in the distal direction causes the catheterbranching site 112 to contact the posts 74, 78. The posts 74, 78, beingof rigid construction, prevent further longitudinal movement.

In other embodiments, the retainer 20 may provide only one set of posts74, 78 to retain a catheter 8 with three branches 114, 116, 117. Forexample, in some embodiments it may be desirable to provide a retainer20 capable of supporting both two-branched and three-branched catheters8, by positioning a single set of posts 74, 78 off-centered within thechannel 60 such that two branches can be placed to one side of theposts. Thus, one set of posts 74, 78 can restrict the longitudinalmotion of a three-branched catheter 8. Similarly, a retainer 20 with twosets of posts 74, 78 can be shaped to also accept two-branched catheters8. In some embodiments, it may be desirable to provide a system ofcatheters and a retainer 20 such that a set of catheters with differentnumbers of branches, sizes, materials, etc. can all be retained by thesame retainer 20. As an example, the set of catheters may each compriseat least one branching site with a set of branches that can be supportedby the single system retainer, and if necessary also comprise furtherbranches extending from one or more additional branching sites proximalor distal from the retainer 20.

Although the posts 74, 78 can have a variety of cross-sectional shapes,the posts 74, 78 desirably have a generally semi-circularcross-sectional shape in the present application so as to correspond tothe space between the catheter branches 114, 116, 117 and/or the webbing120 at the branching site 112. The proximal edge of the postsadvantageously is rounded to eliminate sharp contact between thecatheter 8 and the retainer 20 at this location. The surface of theposts 74, 78 can thus comprise a contact surface configured to abutagainst the branching site 112 so as to inhibit movement of the securedportion of the catheter S in at least one direction. In otherembodiments, the cross-sectional shape may be generally triangular,square, elliptical, or generally resemble some other polyhedron orsmooth geometric shape, optionally matching the shape of the branches114, 116, 117 or the webbing 120.

The posts 74, 78 can also include interengaging elements to interlockthe posts 74, 78 in the transverse direction. In the illustratedembodiment, a pin or projection 81 and a corresponding receptacle 79 arearranged between the interfacing ends of the posts 74, 78. As best seenin FIGS. 4, 6, the receptacle 79 is formed at the transverse end of thecover post 78, extending into the post 78 in a transverse direction froman interface surface of the post 78. The projection 81 extends from anend of the base post 74 in a direction parallel to a transverse axis ofthe post 74. The projection 81 is configured to fit within thereceptacle 79. When the cover 24 is closed, the projection 81 extendsinto the receptacle 79 to interlock together the posts 74, 78.

Another possible retention element to inhibit axial movement of thecatheter 8 relative to the retainer 20 involves protuberances that arearranged to cooperate with one another when the cover 24 is closed. Forinstance, in one mode, the cooperating posts 74, 78 can be arranged tocapture a structural portion of the catheter (e.g., the catheter webbing120) between them without substantially occluding an inner lumen of thecatheter 8, such as in FIGS. 15, 16. In another mode, the projection 81can be employed without the receptacle 79 to simply pin a portion of thecatheter (e.g., its webbing) against a surface of the retainer 20. Forinstance, the projection 81 can extend from a portion of either the base22 or the cover 24 and cooperate with a corresponding surface (e.g. apost, platform or channel surface) that opposes the projection 81 whenthe cover is closed. The projection 81 would protrude into the portionof the catheter and pin it against the corresponding surface.

Alternatively, the projection 81 can be used with the receptacle 79 tocapture a section of the catheter. When the cover 24 is closed, theprojection 81 could force a portion of the catheter body 8 into thereceptacle 79 to capture a structural portion of the catheter 8 betweenthese components without occluding an inner lumen of the catheter. Thisengagement of the retainer 20 with the catheter body 8 would inhibitaxial catheter movement relative to the retainer 20.

In another embodiment, depicted in FIGS. 21-29, the webbing 120 of thecatheter 8 can be provided with receptacles or holes 250 (best shown inFIG. 25). The base posts 74 can extend through the holes 250 in thewebbing 120 and interlock with the cover posts 78 to secure the catheter8. This can secure the catheter 8 so as to prevent movement in both aproximal and distal direction. Additionally, protruding through morethan one hole 250, as shown in the figures, can further prevent rotationin a plane perpendicular to the transverse direction. The base posts 74may be shaped to fit the holes 250, and in some embodiments the holesmay be oversized relative to the base posts to allow easy insertion. Asa further example, in some embodiments base posts 74 can protrudethrough at least three non-collinear holes 250, thus preventing rotationin all dimensions (before accounting for play between the posts andholes).

One or more securement protrusions 270 can also be used to retain thecatheter in the longitudinal direction. In the illustrated embodiment,each protrusion 270 has a generally conical shape with a radiused orblunt tip. The protrusion 270, in the present application, desirablyextends into the channel 60 by an amount ranging between about 0.1 mmand about 3 mm.

The retainer 20 desirably includes at least one set of securementprotrusions 270 arranged within the channel 60 to cooperate with oneanother. The protrusions 270 can advantageously be arranged collinearlyon the same generally lateral line, and are spaced apart from oneanother. In addition, the protrusions 270 can be spaced on generallyopposite surfaces 69 of the channel 60 in a staggered arrangement. Thatis, the position of the protrusions 270 can alternate between the coversurface and the base surface in the lateral direction. The resultingoverlapping pattern of the protrusions 270 can securely hold thecatheter 8 without imparting torque to the catheter 8 if pulled in alongitudinal direction. As best shown in FIG. 6, the protrusions 270 arepositioned generally opposite each other, and in pairs on the surface ofthe cover 24 and the surface of the base 22, between the posts 74, 78.These protrusions 270 are spaced apart from one another and the pair issymmetrically positioned relative to a longitudinal axis that extendsalong the drainage branch 116. The distance between each pair ofprotrusions 270 can vary between the opposite surfaces of the channel60. As best shown in FIG. 20, the protrusions 270 on the base surfaceare closer together than the protrusions on the cover surface, spreadingcompressive forces across the diameter of the catheter 8. In otherembodiments, the protrusions 270 can be closer on the cover surface thaton the base surface, or the protrusions can be staggered in some othermanner such as alternatingly or longitudinally. The drainage branch 116can rest in between the protrusions 270 without excessive pinching ofthe branch 116.

The retainer 20 can also include additional sets of securementprotrusions 270 arranged generally in accordance with the abovedescription, but on another side of either of the posts 74, 78 so as tointeract with the inflation or auxiliary branches 114, 117 of thecatheter 8. It may be desirable to provide fewer protrusions 270, aswell as fewer sets of protrusions, in these regions of the retainer 20.In some embodiments it may be desirable to angle the protrusions 270toward either the distal end or the proximal end of the channel 60 toinhibit movement of the branches in the opposite direction. In otherembodiments, for example, when other retaining members are used, theprotrusions might not be necessary, such as in the embodimentsillustrated in FIGS. 21-29.

When securement protrusions 270 are used to hold the catheter 8, thecatheter will tend to bulge around the protrusions. Thus, providing arecessed portion 280 (as discussed above) can create additional spacewithin the channel 60 for the catheter to bulge into. By creating spacefor the catheter 8 to bulge outward, the catheter can accommodate theprotrusions 270 without kinking inward and potentially occluding theinterior lumen.

As illustrated in FIGS. 14-16, 26-28, a healthcare provider can secure aFoley catheter (or other medical article) to a patient using theabove-described anchoring system (or a readily apparent modificationthereof). The healthcare provider first opens the retainer 20 to exposethe groove 30 on the base 22. Once opened, a catheter 8 can betransversely aligned over the groove 30. The catheter 8 can then beplaced into the channel 60. If the channel 60 is formed with a post 74(or another protuberance) for use with a branching site, the branches114, 116, 117 are aligned around the posts 74 and the catheter branchingsite 112 is aligned to securely fit within the remaining grooveconfines. Similarly, if the base posts 74 are intended to pass throughholes 250 in the catheter webbing 120, such holes and posts are alsoaligned. Once the catheter 8 is so aligned and placed into the groove30, the cover 24 is closed and latched in the manner described below.The shapes of the grooves 30, 36 can ensure that the channel supportsthe catheter branching site 112 on at least diametrically opposed sidesthereof along the entire retained length of the catheter branching site.This not only enhances frictional contact between the retainer 20 andthe catheter 8, but it also prevents the catheter 8 from kinking orcrimping with the retainer 20 and thereby occluding one or more of thecatheter lumens.

In the illustrated embodiment, the posts 74, 78 come together with theprojection 81 inserting into the receptacle 79 when the cover is closed.The posts 74, 78 therefore are interlocked in this position to form astop on the distal side of the branching site 112 that spans entirelyacross the channel's transverse length. The securement protrusions 270also can bite into the body of the catheter branching site 112 to resistmovement of the catheter branches 114, 116, 117 in a direction oppositeof the direction in which they are angled.

If the catheter 8 is pulled in the proximal direction, the tapered shapeof the channel 60 inhibits the larger distal end of the branching site112 and the valve on the inflation branch 114 from pulling through theretainer. An additional set of securement protrusions, which bite intothe inflation and/or auxiliary lumen branches 114, 117 can also inhibitmovement of the catheter in this direction. And if the retainer employsposts or projections that clamp onto, pin, or pass through the catheterwebbing within the channel, then this engagement between the retainerand the catheter would further secure the catheter in place.

If the catheter discharge branch 116 is pulled in the distal direction,the interlocked posts 74, 78 inhibit this movement. The set ofsecurement protrusions 270 bite into the discharge branch 116 and alsooppose movement of the catheter branch 116 in this direction. A distalpulling force on the discharge branch 116 also tends to pull theinflation and auxiliary lumen branches 114, 117 around the posts 74, 78.Additional sets of securement protrusions can also inhibit this reactionto further anchor the catheter branching site 112 within the retainer20.

The retainer 20 thus inhibits longitudinal movement of the catheter 8relative to the retainer, even when used with a lubricated catheter. Theholding effect provided by each of the retention elements, however, doesnot substantially occlude the lumens of the catheter. The interaction ofthe protuberances (i.e., the posts and/or projection) only affects thecatheter webbing 120 (or like structure) and does not bear against thecatheter body. Likewise, the interaction between the shape of thechannel 60 and posts 74, 78 restricts movement of the catheter 8 in bothaxial directions, but does not crimp or kink the catheter body when itis inserted within the channel and about the posts. Further, althoughthe securement protrusions 270 bear against the catheter body, theirlimited bite does not significantly occlude or penetrate thecorresponding catheter lumen. To further prevent occlusion of thecatheter lumen, the recessed portions 280 provide space for the catheter8 to bulge outward, and not inward.

The illustrations of the retainer including some of the above-describedforms of the retention elements are merely examples. The retainer caninclude only one retention element of any given type or possiblyseveral; it can but need not include all types. In addition, anycombination of the retention elements in the retainer is also possible.

The present anchoring system thus provides a sterile, tight-gripping,needle- and tape-free way to anchor a medical article to a patient. Theretainer thus eliminates use of tape, and if prior protocol requiredsuturing, it also eliminates accidental needle sticks, suture-wound-siteinfections and scarring. In addition, the retainer can be configured tobe used with any of a wide variety of catheters, tubes, wires, and othermedical articles. Patient comfort is also enhanced and application timeis decreased with the use of the present anchoring system.

As further described below, the retainer 20 can rotate by at least somedegree, and preferably by 360 degrees, relative to the anchor pad 12.For this purpose, in the illustrated embodiment, the mounting base 242is attached to the anchor pad 12 and includes a post 226. A hole 232 isformed in the base 22 of the retainer 20 to receive the post 226.

As best seen in FIGS. 1, 2, 10A, 10B, the mounting post 226 is attachedto the anchor pad 12 and the through-hole 232 is formed in the base 22of the retainer 20. The mounting post 226 and through-hole 232 allow theretainer 20 to pivot relative to the anchor pad 12. In the illustratedembodiment, the retainer 20 can be rotated 360 degrees relative to acentral pivot point fixed to the anchor pad 12; however, the degree ofrotation also can be confined.

Relative rotation is advantageous to assist the healthcare provider inattaching and detaching the retainer 20 to the catheter. Relativerotation is also advantageous to assist the healthcare provider inadjusting the attached catheter—retainer assemblage so that the catheteris less likely to become kinked or snagged on an object. Relativerotation is further advantageous to assist in positioning the catheterin-line with the drainage lumen or other object. In addition, thehealthcare provider need not precisely align the retainer relative to anaxis of the catheter before attaching the pad to the patient's skin. Thehealthcare provider can coarsely align the anchoring system on thepatient, adhere the pad to the patient's skin, and then rotate theretainer to align the channel of the base with the axis of the catheter.The rotatable nature of the retainer thus eases connection anddisconnection of the catheter with the retainer.

As best seen in FIGS. 10A, 10B, the illustrated mounting post 226comprises a pedestal 228 and a cap 230 configured for acceptance into athrough-hole 232 formed in the base 22 of the retainer 20. The pedestal228 is attached to and extends upwardly from the anchor pad 12. Thepedestal 228 can have a variety of transverse heights, depending uponthe particular application and the particular retainer to which itinteracts. For anchoring Foley catheters and for use with some exemplaryretainers described herein, the pedestal 228 desirably has a transverseheight slightly smaller than that of the base 22 at the location of thehole 232; that is, the height can be about 1-5 mm, and more particularlyabout 2 mm; however, other heights are also possible. The illustratedpedestal 228 has a generally cylindrical shape, but can be configured ina variety of other shapes, which can match the shape of the hole 232 inthe retainer base 22. The diameter of the pedestal 228 is sufficient toperform its structural function of coupling the anchor pad 12 to thebase 22 without significantly bending or breaking and desirably has adiameter of about 1 to 5 mm and more particularly a diameter of about 4mm; however, larger or smaller diameters are also possible. Thus, thediameter of the pedestal 228 is desirably about twice the height of thepedestal 228. The pedestal 228 can be flared at the bottom to form anannular fillet (not shown). The fillet can provide structural strengthto the pedestal 226 to resist shear and other forces that can otherwisecause the pedestal to break off from the mounting base 242 or otherwisefail. In other embodiments, the pedestal 228 can form a right angle withthe mounting base 242.

The cap 230 extends radially outward from the top portion of thepedestal 228. The cap 230 assists in coupling the anchor pad 12 to thebase 22 by inhibiting separation of the pedestal 228 from the base 22,as explained below. The radial diameter of the cap 230 can vary,depending upon the particular application, and desirably is about 1-5mm, and more particularly a diameter of about 2 mm; however, larger orsmaller diameters are also possible. The illustrated cap 230 has a crosssectional shape generally similar to that of the pedestal 228 for easeof manufacture, however, it can be configured in a variety of othercross sectional shapes to generally match the shape of the through-hole232 in the base, which is described below. The cap 230 desirably extendsbeyond the circumference of the pedestal 228 to assist in securelycoupling the anchor pad 12 to the retainer 20, however, the cap 230 neednot circumscribe the entire pedestal 228 and can comprise only a singleradial member that extends outwardly from the pedestal 228. Thetransverse thickness of the cap 230 is sufficient to perform itsstructural function of coupling the anchor pad 12 to the retainer 20without significantly bending or breaking and desirably has a thicknessof about 0.5 to 2 mm and more particularly a thickness of about 1 mm;however, larger or smaller thicknesses are also possible. A chamfer 234can be formed on an upper peripheral edge of the cap 230 to assist inthe assembly of the mounting post 226, as described below. Theillustrated chamfer 234 transversely extends for about one-half thethickness of the cap 230.

The mounting post pedestal 228 desirably has smooth side surfaces tofacilitate sliding of the retainer 20 relative to the mounting post 226,such that the mounting post 226 provides a bearing surface for theretainer base 22. The top of the cap 230 additionally is smooth andplanar to present a surface that is generally flush with the surface ofthe base 22 within the channel. It is understood, however, that in theillustrated embodiment the curvilinear configuration of the channelsurface of the base 22 and manufacturing variation can result in animperfectly flush surface between the base and the cap 230. To preservethe integrity of the channel, it will generally be preferred that thecap 230 reside slightly below the channel surface so as to ensure itdoes not protrude into the channel 60 due to variation in manufacturingor a non-flat channel. The mounting post 226 has a one-piece unitaryconfiguration for ease of manufacture and strength; however, themounting post 226 can alternatively comprise a plurality of separatecomponents that attach to form the mounting post 226. Although theillustrated mounting post 226 is generally mushroom shaped with agenerally flat top, the mounting post 226 can also be generallyT-shaped, inversely L-shaped and the like.

The mounting post 226 is desirably formed in unity with a mounting base242 for structural strength; however, the mounting post 226 and themounting base 242 can comprise separate components, as noted below. Themounting base 242 provides a larger footprint, relative to that of themounting post 226, so that the mounting post 226 can be more securelyattached to the anchor pad 12 and inhibit unintended separation of themounting post 226 from the anchor pad 12. For example, if the anchoringsystem 10 is adhered to the inner thigh of a bedridden patient, movementof the patient can generate forces on the anchoring system 10. Thus, thelarger footprint which the mounting base 242 provides, and which themounting post 226 is preferably in unity with, provides increasedsecurement between the mounting post 226 and anchor pad 12 and enhancesthe robustness of the anchoring system.

The mounting base 242 is generally planar to match the upper surface 14of the anchor pad 12. The illustrated plate also has a circularconfiguration, with the mounting post 226 located at the center of theplate so that the retainer 20 can centrally rotate on the mounting base242; however, the base can have other shapes as well.

In some embodiments, an upturned lip (not shown) desirably circumscribesthe perimeter of the mounting base 242 to form a barrier that inhibitsinwardly directed radial forces from shearing or otherwise separatingthe retainer 20 or mounting post 226 from the mounting base 242. The liphas a transverse height of about 1-5 mm for this purpose. The lipdiameter is slightly larger than the lateral width of the retainer 20(i.e., larger by about 1 mm); however, the lip can alternatively bearranged to radially abut the retainer 20 when the retainer 20 rotateson the mounting base 242, or to provide a radial clearance between theretainer 20 and the lip. When so configured, the lip does not interferewith the interengaging structure (i.e., does not extend transverselyabove the latching mechanism so as to inhibit the healthcare provider'sfingers from depressing the latching mechanism, or abut the retainer soas to partially depress the latching mechanism when the retainer isrotated). The lip additionally does not extend above the bottom of thechannel 60 and thus does not present an edge about which the cathetercould kink. In the illustrated embodiment, the lip is shorter than themounting post 226. The lip also does not interfere with the freerotation of the retainer; however, the mounting base 242 and theretainer 20 can include cooperating structure which establishesincremental angular positions of the retainer as it rotates over themounting base 242. This can be done by providing a plurality of ratchetteeth about the inner side surface of the lip and a cooperating tangformed on the retainer 20. In this manner, the orientation of theretainer 20 on the mounting base 242 can be set until a sufficient forceis applied to the retainer to overcome the engagement between the tangand the corresponding ratchet teeth.

In the illustrated embodiment, as best understood from FIGS. 10A, 10B,the base 22 of the retainer 20 has a through-hole 232 sized andconfigured to recover the post and more preferably to generally matchthat of the mounting post 226 so that the retainer 20 can rotaterelative to the anchor pad 12 about the mounting post 226. Theillustrated through-hole 232 extends through the base 22 and has adiameter slightly larger than that of the pedestal 228 and cap 230. Thetolerance between the through-hole 232 and the mounting post 226desirably is about 0.1-0.5 mm and more particularly about 0.1-0.2 mm.Like the mounting post 226, the through-hole 232 has a smooth surface tominimize friction when the retainer is rotated. A chamfer (not shown)can circumscribe the lower portion of the hole 232 to assist in theassembly of the rotatable mounting post 226, as described below.

When assembled, the mounting post 226 is arranged within thethrough-hole 232 and secured to the anchor pad 12. In particular, thetop of the cap 230 is generally flush with the top of the base 22 andthe bottom of the pedestal 228 is secured to the anchor pad 12. Themounting base 242 is desirably secured to the upper surface 14 of theanchor pad 12 by a solvent bond adhesive, such as cyanoacylate or otherbonding material. One such adhesive is available commercially as PartNo. 4693 from the Minnesota Mining and Manufacturing Company (3M). Onesuitable assembly process, advantageously used when the mounting post226 and mounting base 242 are formed in unity, involves bonding thebottom of the mounting base 242 to the upper surface 14 of the anchorpad 12 and then urging the cap 230 of the mounting post 226 through thethrough-hole 232. A chamfer that circumscribes the through-hole 232 andthe chamfer 234 that circumscribes the cap 230 can cooperate to allowthe cap 230 to deform and advance through the through-hole 232. Anothersuitable assembly process, advantageously used when the mounting post226 and mounting base 242 comprise separate components, involves placingthe pedestal 228 through the through-hole 232 such that the pedestal 228extends through while the cap 230 catches on the second diameter 238,then bonding the bottom of the pedestal 228 to the mounting base 242,and then bonding the mounting base 242 to the anchor pad 12. By thisconfiguration, the retainer 20 can rotate 360 degrees relative to theanchor pad 12.

FIGS. 4, 5 shows the top and bottom of the cover 24 having indicia 224,225 such as a directional arrow, to orient the healthcare provider. Theindicia 224 directs the positioning of the retainer 20 with respect tothe catheter and the patient. The retainer 20 is desirably arranged sothat the arrow points toward the catheter insertion point, and in adirection generally parallel to the longitudinal axis of the catheter 8.Providing indicia 224 on the top of the cover 24 can convey informationto the healthcare provider while the retainer 20 is in the closedposition. However, this indicia 224 is not visible to the healthcareprovider when the retainer 20 is in the open position. Thus, providingindicia 225 on the bottom of the cover 24 can provide information to thehealthcare provider when the retainer 20 is in the open position.

To firmly hold the affected catheter portion within the channel, thebase 22 and the cover 24 include interengaging structure to couple themtogether in the closed position. In the illustrated embodiment, as bestseen in FIGS. 18-20, a latch mechanism 80 is used to secure the cover 24to the base 22. The latch mechanism 80 comprises at least one moveablekeeper 88, at least one latch post 260, and at least one receptacle 104.The keeper 88 is arranged on the cover 24 while the receptacle 104 isarranged on the base 22; however, these components can be flip-floppedon the base and the cover.

As best seen in FIGS. 4, 8, 18-20, each keeper 88 includes a bar 92extending toward the base 22 from the second side 34 of the cover 24.Two tangs 94 are formed at a lower end of the bar 92. Desirably, thelower end of the tangs 94 are relatively blunt and smooth to preventthem from puncturing the gloves or skin of a healthcare provider orcatching on other materials. An operator lever 98 extends to the side ofthe bar 92 and includes an enlarged platform or ear at its outer end.The operator lever 98 is angled upwardly from the bar 92 when the cover24 is in the closed position. In this way, downward force upon theoperator lever 98 produces a force component which causes the bar 92 todeflect inwardly, allowing the tangs 94 to disengage from notches 106 onthe base 24. The entire keeper 88 desirably is formed with the cover 24to form a unitary piece.

The base 24 includes a receptacle 104 that receives the bar 92 and thetangs 94. The latch receptacle 104 includes inner notches 106 into whichthe tangs 94 snap when the cover 24 is in the closed position; however,the tangs can be arranged in the receptacle and the notches bepositioned on the bar to accomplish the same effect. The receptacle 104desirably is formed with the base 22 as a unitary piece.

In the illustrated embodiment there are two tangs 94 and two notches 106disposed symmetrically from front to back on the retainer. Each notch106 is arranged to receive one of the keeper tangs 94 when the cover 24is closed.

An entrance of the receptacle 104 includes chamfer edges. The chamferedges slope inward toward the center of the receptacle 104 to cause thekeeper bars 92 to bend inward when inserting the keepers 88 into thelatch receptacle 104.

As best understood from FIGS. 4, 6, the second side 28 of the base 22also includes a slot 108 to receive a portion of the operator levers 98and the bar 92 of the keepers 88 when the associated tangs 94 areinserted into the receptacle 104.

In some embodiments, the latch 80 can further comprise one or more latchposts 260 and one or more latch post receiving portions 261, as bestdepicted in FIGS. 4 and 18-20. As in the illustrated embodiment, thelatch post 260 extends from the cover 24 to enter the latch postreceiving portion 261 on the base 22. In this embodiment the latch post260 comprises a substantially close fit with the latch post receivingportion 261. The latch post 260 and receiving portion 261 are locatedfurther inside the retainer 20 relative to the bar 92. As shown, thelatch post 260 has a taper and a smooth surface, matching the taper andsmooth surface of the receiving portion 261, such that the latch postcan be easily inserted.

In operation, the cover 24 can swing toward the closed position. Therelatively thin strip of material forming the coupling allows the hinge40 to bend when finger pressure is exerted on the cover 24 to close it.The lower ends of the tangs 94 contact chamfered edges of the latchreceptacle 104 when the cover 24 nears its closed position. Continuedpressure forces the bar 92 inward to permit the tangs 94 to pass throughthe receptacle. The slot 108 of the receptacle 104 receives the operatorlever 98 as the tangs 94 are pushed further into the receptacle 104. Thetangs 94 snap into the notches 106, under the spring force provided bythe deflected bar 92 when the cover 22 sits atop the base 24. Theinteraction between the tangs 94 and the corresponding surfaces of thenotches 106 hold the cover 24 in this position. As best seen in FIG. 20,the operator lever 98 extends to the lateral side of the base 24 whenthe cover 24 is latched.

A healthcare provider presses downward on the operator lever to open thelatch mechanism 80. A downwardly force applied to the angled outersurface exerts an inward force component which deflects the bar 92inward and releases the tangs 94 from the notches 106. The inherentspring force stored in the bent hinge band assists with providing atransverse force that moves the keeper 88 out of the receptacle 104. Thehealthcare provider can then open the cover 24 and expose the innergrooves 30, 36 of the base 22 and the cover 24.

Certain interengaging elements arranged between interfacing portions ofthe base 22 and the cover 24 further provide an inherent spring force.As best shown in FIG. 4, the illustrated embodiment shows two sets ofinterengaging elements, one set arranged near the hinge 40 and one setarranged near the latch mechanism 80. Each set of interengaging elementsinclude a pin 220 that extends from the cover 24 and a receiver 222 thatrecedes into the base 22. The pin 220 is configured to fit within therecess 222 so that when the cover 24 is closed, the pin 220 extends intothe recess 222 to interlock the base 22 and cover 24 together. Thetransverse length of the pin 220 is desirably sized slightly larger thanthe transverse depth of the receiver 222 (e.g. about 0.05-0.5 mm). Bythis arrangement, when the cover 24 is in the closed position, the firstside 32 of the cover 24 is offset from (i.e., not in contact with) thefirst side 26 of the base 22. Thus, the internal spring force stored inthe interengaging elements can also provide the suitable transverseforce to assist in opening the cover 24. The interengaging elements alsoserve to interlock the base 22 and the cover 24 in the longitudinal andlateral directions, similar to that of the projection 81 and receptacle79 of the previous embodiment.

Under the deflection of both opening and closing the retainer 20, thelatch post and receiving portion 260, 261 act to constrain thisdeflection to the bar 92 and prevent similar deflection in the cover 24or the base 22. Absent the latch post and receiving portion 260, 261 thedeflecting force could cause the cover 24 and base 22 to bow away fromeach other, potentially causing undesirable pinching or kinking of thecatheter 8 upon closing of the retainer 20. A latch post and receivingportion 260, 261 that substantially match each other can act to resistbowing of the cover 24 relative to the base 22. Thus, the latch post andreceiving portion 260, 261 can provide structural support to the latch80. As best shown in FIG. 19, when the latch 80 is in transition betweenopen and closed positions the latch post 260 deflects backward to pushagainst the latch post receiving portion 261. Absent this structure, thedeflecting force could travel the length of the cover 22.

The releasable engagement between the cover 24 and the base 22 allowsthe same retainer 20 to be used even when opened and closed multipletimes. This allows for repeated attachment and reattachment of thecatheter to the anchoring system 10. In addition, the hinged connectionconnecting the cover 24 to the base 22 ensures that the cover 24 willnot be lost or misplaced when the catheter is detached from theanchoring system 10. The healthcare provider wastes no time in searchingfor a cover, nor in orienting the cover prior to latching.

The catheter 8 can comprise a number of materials, including silicone,latex, plastics, rubber, polypropylene, thermoplastics, or othermaterials. In a preferred embodiment a silicone catheter is used. Theretention elements (e.g. protrusions 270, channel 60, posts 74, 78,etc.) can be included, shaped, and positioned according to the materialused. For example, a catheter 8 comprising a material with strongerfrictional forces may require fewer and/or weaker retention elements onthe retainer 20 to hold it in place. A catheter 8 comprising a material,shape, or size that easily kinks may require relatively broader and morefinely adapted retention elements on the retainer 20 to sufficientlyhold it in place and prevent kinks.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. In addition, while a number of variations of the invention havebeen shown and described in detail, other modifications, which arewithin the scope of this invention, will be readily apparent to those ofskill in the art based upon this disclosure. It is also contemplatedthat various combinations or sub-combinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the invention. Accordingly, it should be understood thatvarious features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the disclosed invention. Thus, it is intended that the scope ofthe present invention herein disclosed should not be limited by theparticular disclosed embodiments described above, but should bedetermined only by a fair reading of the disclosure and the claims thatfollow.

What is claimed is:
 1. A securement device for securing an elongatedmedical article, the device comprising: an anchor having an uppersurface and a lower surface, at least a portion of the lower surfacebeing formed with an adhesive layer; a retainer including a base and acover, the cover being moveable with respect to the base between an openposition and a closed position, each of the base and the cover having agenerally curvilinear groove, the grooves together forming a channelwhen the cover is in the closed position, the channel supporting asecured portion of the elongated medical article at least when the coveris in the closed position; and a latching mechanism operable between thebase and the cover to releasably secure the cover to the base when thecover is in the closed position, the latching mechanism including akeeper, a latch, a latch post, and a latch post receiving portion, thekeeper having at least one member capable of interengaging with at leasta portion of the base, and the latch having a recess for accepting atleast a portion of the at least one member when the cover is in theclosed position, the latch post deflecting toward the latch postreceiving portion and pushing against the latch post receiving portionduring transition between the open and closed position so as tostructurally support the latching mechanism.
 2. The securement device ofclaim 1, further comprising an operator lever configured to be actuatedby a fingertip of a healthcare provider to deflect the at least onemember of the keeper to disengage the at least one member from therecess of the latch in order to move the cover from the closed to theopen position.
 3. The securement device of claim 2, further comprising arelief within which the operator lever lies when the latch is in theclosed position and which allows the at least one member to deflect asthe cover is moved from the open to the closed position.
 4. Thesecurement device of claim 1, wherein the latch post is offset from thelatch post receiving portion in the closed position.